Remote Cardiovascular Monitoring in Post-TAVI Patients
Recruiting now · Not applicable
Conditions studied: Aortic Valve Stenosis, Cardiac Conduction Disturbance, Digital Health, Transcatheter Aortic Valve Implantation, TAVI
In brief
The goal of this randomised clinical trial is to utilise a remote monitoring algorithm to gather essential clinical data, aiming to guide the management of post-Transcatheter Aortic Valve Implantation (TAVI) patients and reduce both postprocedural hospital length of stay and readmissions. This strategic integration of technology aims to address gaps identified in previous studies and enhance the effectiveness of post-TAVI patient care. One significant concern after TAVI is the development of heart conduction abnormalities on the ECG and abnormal rhythms, such as heart block, potentially requiring permanent pacemaker insertion. Addressing these rhythm issues is crucial for reducing the overall length of stay. The main question it aims to answer is: Does a remote patient monitoring protocol-driven strategy reduce post-TAVI hospital length of stay and adverse events? Participants post-TAVI procedure and eligible for same-day discharge, as determined by their primary cardiologist, will be randomized upon informed consent into the active arm (remote monitoring) or control group (standard of care). Participants in the active arm will: receive four remote monitoring devices. Receive support from a validated clinical decision-making algorithm for further management. Participants in the control group will: adhere to the best standard of care as per current practice. Researchers will compare the active arm to the control group to see if the remote patient monitoring protocol-driven strategy reduces post-TAVI hospital length of stay and adverse events.
Key facts
- Study ID
- NCT06602609
- Run by
- Imperial College London
- People needed
- 216
- Starts
- 2024-11-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient age must be 18 years or above.
- Post-TAVI patients without serious complications hindering same-day discharge, including vascular, neurological, and cardiac postprocedural complications necessitating inpatient care:
- Vascular: Controlled with adequate vascular hemostasis.
- Neurological: Conscious and oriented, not under the effect of residual sedation.
- Cardiac: No significant pericardial effusion.
- Elective non-emergent patient admission and nonelective cases fitting discharge criteria.
- Comfortable ambulation post-procedure.
- The patient or their caregiver must have access to a smart device.
- Ability to provide informed consent (the patient must be alert and oriented for consent).
- Adequate social support.
You may not qualify if…
- Hemodynamically unstable post-TAVI condition, periprocedural cardiac arrest, cerebral vascular accident, acute kidney injury (AKI) and major/life-threatening bleeding requiring blood transfusion.
- Patients with a permanent (pre-existing or new) implanted pacing device.
- Procedural failure in device delivery.
- Major vascular access complications require patients to stay.
- Inability to engage with the technology.
- Significant communication barrier.
Where it is running
- Hammersmith Hospital — London, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.